Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approved indication is for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Drug Background
Entrectinib, the first ROS1 inhibitor with clear central nervous system (CNS) efficacy to become available in China, was initially approved in late July to treat NTRK fusion-positive solid tumors. The second indication approval comes less than two weeks later.
Global Approvals
Entrectinib, a selective TRK / ROS1 inhibitor with CNS activities that can penetrate the blood-brain barrier, has already been approved in Japan, the US, and the European Union for the treatment of NTRK fusion-positive solid tumors and ROS1-positive advanced NSCLC. The drug was first approved in China in July 2022, making it the second NTRK inhibitor in the country following Bayer’s Vitrakvi (larotrectinib).-Fineline Info & Tech
